ProteinEXact™ AssayFor the LabChip® GXII Touch™ Protein Characterization System

For research use only. Not for use in diagnostic procedures.

Bring high sensitivity to your protein quantitation and sizing applications with the ProteinExact™ assay for the LabChip® GXII Touch™ protein characterization system. The ProteinEXact™ assay is ideal for use in both upstream and downstream biotherapeutics workflows which require the utmost in precision. With the analytical power and speed of the LabChip® GXII Touch™ protein characterization system and IntelliChip™ assay optimization technology, you can accelerate your protein development workflows with high-precision reproducibility, sensitivity, and an expanded sizing range.

• Dependable reproducibility for quantitation (<10% CV) and sizing (<2% CV) • Broad sizing and quantitation range: 6.5-250 kDa and 10-2000 ng/μL • Highly sensitive: 0.2 ng/μL • Flexible: Run in batches of 48 or 96 samples at a time • Fast: Analysis in ~65 sec per sample

The LabChip® GXII Touch™ automated capillary electrophoresis platform delivers comparable results to traditional capillary electrophoresis with 46X faster run times without compromising sensitivity, resolution or reproducibility.

LASER PRECISION:PROTEINEXACT™ ASSAY

Figure 1. Electropherogram overlays and corresponding virtual gels for samples run 3 times at low (a) and high (b) concentrations.

Reproducibility

Low Concentration

High Concentration

A

B

PROTEINEXACT™ REPRODUCIBILITY, SENSITIVITY, & SIZING RANGE

Sensitivity

Expanded Sizing Range

Figure 2. The sensitivity of the ProteinEXact™ assay is demonstrated by overlaying the ProteinEXact™ ladder (red) with the same ladder, diluted 300X in water (blue). The ProteinEXact™ assay provides high sensitivity across an expanded concentration range.

Figure 3. Overlays of Protein Express assay ladder and ProteinEXact™ assay ladder demonstrate the newly expanded sizing range.

LabChip® GXII Touch™ Protein Characterization System Software

The LabChip® GXII Touch™ System and Reviewer Software contains built-in technical controls and features specifically designed to be compatible with 21 CFR Part 11 requirements. These features include a shared user account database, access controls, device check, enforced sequencing of run steps, audit trails, record copying, record retention, system documentation, and electronic signature controls. LabChip® Touch™ instruments generate data records in electronic form which are archived in a Central Data Repository. The LabChip® GX (GxP) Reviewer application can be run from any computer connected to the instrument network and allows modification and maintenance of the records with the ability to perform electronic signatures on the records generated from instruments in the lab system. The robust and comprehensive LabChip® GXP Software uses secured, computer-generated, time-stamped audit trails to independently record the date and time of operator entries and actions that create, modify, or delete electronic records (Figure 4). In addition, unique combinations of user ID and password for electronic signature are used. Once locked, a record cannot be further modified without a separate signed unlock action (Figure 5).

Figure 4. Audit trail Figure 5. Perform signature

ProteinEXact™ Assay Specifications

Sizing Range 6.5 kDa - 250 kDa

Sizing Precision RSD (CV) <2%

Sizing Resolution ≤10%

Linear Dynamic Range 10-2000 ng/µL

Maximum Total Protein Concentration 2 mg/mL

Sensitivity Limit of Detection (LOD) 0.2 ng/µL

Quantitation Reproducibility <10%

Maximum Salt Concentration 1M NaCl at pH 6.5 to 8.5

Chip Primes per Reagent Kit 10

Chip Sample Lifetime 400

Sample Analysis Time 65 sec

Assay LabChip® GXII Touch™ HT Chips LabChip® GXII Touch™ 24 Chips Reagent Kit

ProteinEXact™ Assay CLS150337 CLS150338 CLS150466

System Requirements: Running of the ProteinEXact™ assay requires a LabChip® GXII Touch™ protein characterization system with V1.7.819.0 software or newer and Data Reviewer V5.5.2312.0 or newer

Ordering Information

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